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The Melanoma Genomics Managing Your Risk Study: examining the impact of personal melanoma genomic risk information on prevention behaviours in the general population

The Melanoma Genomics Managing Your Risk Study: a randomised controlled trial of the efficacy of personal melanoma genomic risk of information, compared to standard prevention advice, in motivating reduced exposure to ultraviolet radiation in the general population

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000691347
Enrollment
1025
Registered
2017-05-15
Start date
2017-08-21
Completion date
2019-01-14
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the Managing Your Risk Study is to evaluate the efficacy of personal genetic risk of melanoma information, compared to standard prevention advice, in motivating preventative behaviours in the general population. Who is it for? You may be eligible to enroll in this trial if you are aged between 18 and 69 years, have European ancestry, and have never had a melanoma. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive personalised genetic risk of melanoma information and an educational booklet on melanoma preventive behaviours, or to receive the educational booklet only. Participants allocated to the group receiving their genetic risk information will provide a saliva sample using the kit sent via postal mail. This will be used for genetic testing and 2-3 months later, these participants will receive a booklet in the mail containing information on their personal genetic risk of melanoma. With their genetic risk information, participants will be given an educational booklet on melanoma preventive behaviours including sun exposure, sun protection and skin examinations. Within 2 weeks of receiving the mailed booklets, participants will receive a phone call from a genetic counsellor to answer any questions about the information. The other group of participants will receive the educational booklet only, and no genetic risk information information or phone call. All participants will have be able to contact a study-dedicated genetic counsellor at the time of consent to ask any questions they may have. All participants will be asked to complete questionnaires and to wear a specialised wrist-worn device (similar in appearance to a watch or a fitbit) which measures sun exposure for 10 days. All participants will be asked to complete a questionnaire and wear a UV dosimeter at baseline, complete a questionnaire at 1-month after they are sent their booklet(s) and complete a questionnaire and wear a UV dosimeter at 12 months after baseline. A subgroup of ~240 participants will also be asked to wear a UV dosimeter at 1-month after they are sent their booklet(s). It is hoped that the findings from this trial will provide information on whether providing information on personalised genetic risk of melanoma motivates people to undertake preventative and early detection behaviours.

Interventions

Participants randomly allocated to the intervention arm will receive: 1. A mailed saliva collection kit for subsequent DNA extraction and genotyping. 2. Personal genetic risk of melanoma information. About 2-3 months after providing a saliva sample, participants will receive their genetic risk information in a hardcopy booklet sent via postal mail. The booklet, developed as part of our pilot trial (ACTRN12615000356561), presents and describes participants’ individual genetic risk of melanoma usi

Participants randomly allocated to the intervention arm will receive: 1. A mailed saliva collection kit for subsequent DNA extraction and genotyping. 2. Personal genetic risk of melanoma information. About 2-3 months after providing a saliva sample, participants will receive their genetic risk information in a hardcopy booklet sent via postal mail. The booklet, developed as part of our pilot trial (ACTRN12615000356561), presents and describes participants’ individual genetic risk of melanoma using evidence-based risk communication strategies, such as numerical and visual presentations of lifetime absolute risk. Participants reported high satisfaction with the genetic risk booklet in the pilot trial, and we have made minor modifications to enhance clarity for participants in the Managing Your Risk Study. The risk information includes: *An absolute risk percentage showing their remaining lifetime risk of developing melanoma. For example, our pilot study observed remaining lifetime genomic risk estimates of up to 20% but the average risk was around 2-4%. * A risk level: higher than average = top 25% of genomic risk, average = middle 50%, lower than average = bottom 25%; based on quartile cut-points within each age, sex and state strata. The genetic risk booklet also contains simple explanatory information about how a person’s risk is calculated, and what they can do to reduce their risk. 3. A telephone call from the study genetic counsellor. The genetic counsellor will contact all participants in the intervention arm within two-weeks after their genetic risk information is sent via postal mail. The purpose of the phone call is to confirm receipt of the booklet and to answer any potential questions. We expect the phone call will last approximately 10 minutes, depending on the number of questions or discussion points raised by participants. 4. An educational booklet on melanoma preventive behaviours and skin examinations. The educational booklet, developed for our pilot trial (ACTRN12615000356561), is based on SunSmart campaign resources. It includes information on risk factors for melanoma and other skin cancers, recommendations for optimal sun exposure and sun protection behaviours, information about skin examinations including an online video showing step-by-step skin self-examination, and information about Vitamin D. Educational materials are widely used by the Australian general public and, as such, are considered ‘standard care’. In the pilot trial, this educational booklet was rated highly (more than 8 out of 10) in terms of satisfaction by participants.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years
Healthy volunteers
Yes

Inclusion criteria

People from the general population aged 18-69 years with European ancestry, who have never had a melanoma (since this study is primarily aimed at prevention), and have sufficient English to complete the study questionnaires.

Exclusion criteria

Outside the eligible age range, personal history of melanoma, no European ancestry, insufficient English to complete the study questionnaires

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 6, 2026